Auvi-Q

In shortageOrange BookUNIISPLATC R03AA01

Last synced from FDA National Drug Code directory (United States) on June 3, 2026

Identification

Manufacturerkaleo, Inc

CountryUS (United States)

ATC codeR03AA01

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
6084202102
2 DOSE PACK in 1 CARTON (60842-021-02) / .1 mL in 1 DOSE PACK

Annotations

UNII (FDA Substance ID)

YKH834O4BH

EPINEPHRINE

RxCUI 3992

Orange Book

N201739

BXBX

DailyMed SPL labels

1 version tracked

FDA shortage

Currently in shortage

Epinephrine Bitartrate, Lidocaine Hydrochloride Injection

Raw payload (JSON)

{
  "unii": {
    "unii": "YKH834O4BH",
    "rxcui": "3992",
    "inchikey": "UCTWMZQNUQWSLP-VIFPVBQESA-N",
    "display_name": "EPINEPHRINE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "INTRAMUSCULAR",
  "spl_meta": {
    "6180fb40-7fca-4602-b3da-ce62b8cd2470": {
      "match": "brand_token",
      "title": "AUVI-Q (EPINEPHRINE) INJECTION, SOLUTION [KALEO, INC]",
      "spl_version": "21",
      "published_date": "2025-10-06"
    }
  },
  "productid": "60842-021_bde1de46-464f-46b6-bda6-66ce27e21e75",
  "productndc": "60842-021",
  "dosage_form": "INJECTION, SOLUTION",
  "orange_book": {
    "appl_no": "201739",
    "products": [
      {
        "rs": false,
        "rld": true,
        "te_code": "BX",
        "strength": "EQ 0.3MG/DELIVERY",
        "product_no": "001",
        "approval_date": "Aug 10, 2012"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": "BX",
        "strength": "EQ 0.15MG/DELIVERY",
        "product_no": "002",
        "approval_date": "Aug 10, 2012"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "EQ 0.1MG/DELIVERY",
        "product_no": "003",
        "approval_date": "Nov 17, 2017"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "EPINEPHRINE",
  "shortage_reason": "Epinephrine Bitartrate, Lidocaine Hydrochloride Injection",
  "shortage_status": "current",
  "proprietary_name": "Auvi-Q",
  "active_ingred_unit": "mg/.1mL",
  "application_number": "NDA201739",
  "marketing_category": "NDA",
  "nonproprietary_name": "epinephrine",
  "start_marketing_date": "20171117",
  "active_numerator_strength": ".1"
}

Related drugs

Other records sharing ATC code R03AA01.

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